MODIFICATION ORIA SPINAL SYSTEM

Appliance, Fixation, Spinal Interlaminal

ORTHOTEC, L.L.C.

The following data is part of a premarket notification filed by Orthotec, L.l.c. with the FDA for Modification Oria Spinal System.

Pre-market Notification Details

Device IDK023884
510k NumberK023884
Device Name:MODIFICATION ORIA SPINAL SYSTEM
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant ORTHOTEC, L.L.C. 9595 WILSHIRE BLVD. SUITE 502 Beverly Hills,  CA  90212
ContactPatrick Bertranou
CorrespondentPatrick Bertranou
ORTHOTEC, L.L.C. 9595 WILSHIRE BLVD. SUITE 502 Beverly Hills,  CA  90212
Product CodeKWP  
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-11-21
Decision Date2003-08-20
Summary:summary

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